NCT02662959

Brief Summary

Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable or metastatic disease at the time of diagnosis. Systemic therapy was required for the patients with advanced stage. Platinum combined with fluoropyrimidines always were considered as first line treatment. After failure of initial therapy, single agent of taxanes was used as second line treatment. However, there is no relative standard chemotherapeutic regimen in the third therapy except oral anti-angiogenesis drug-Apatinib. So this study was designed to explore the role of single agent with irinotecan as third line treatment in patients with metastatic gastric cancer in China.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Last Updated

January 26, 2016

Status Verified

November 1, 2015

Enrollment Period

3.1 years

First QC Date

April 23, 2015

Last Update Submit

January 21, 2016

Conditions

Stomach Neoplasms

Keywords

Chemotherapy, metastatic gastric cancer, irinotecan

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    From the day enrolled in the study to death

    1 year

Secondary Outcomes (3)

  • Progression free survival

    6 month

  • Objective Response Rate

    8 weeks

  • Number of Adverse Events

    Participants will be followed for the duration of treatment interval, an expected average of two weeks

Study Arms (1)

Irinotecan

EXPERIMENTAL

In the experimental arm, patients receive single agent of irinotecan as third line treatment in metastatic gastric cancer.

Drug: Irinotecan

Interventions

IrinotecanDRUG

180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Irinotecan

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  • Have failed for 2 lines of chemotherapy
  • Life expectancy of more than 3 months
  • ECOG performance scale ≤ 2
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
  • Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
  • More than 4 weeks for operation or radiotherapy
  • More than 4 weeks for cytotoxic agents or growth inhibitors
  • Adequate hepatic, renal, heart, and hematologic functions (platelets \> 100 × 109/L, neutrophil \> 1.5× 109/L, serum creatinine ≤ 1×upper limit of normal(ULN), total bilirubin within 1× ULN, and serum transaminase≤2.5×the ULN).

You may not qualify if:

  • Previously receiving irinotecan treatment
  • Participated other clinical trials within 4 weeks
  • Known Gilbert Syndrome or other biliary tract obstructive disease
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Evidence of CNS metastasis
  • Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
  • Receiving the therapy of thrombolysis or anticoagulation
  • Disability of serious uncontrolled intercurrence infection.
  • Uncontrolled pleural effusion and ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

  • Yu N, Huang S, Zhang Z, Huang M, Wang Y, Zhang W, Zhang X, Zhu X, Sheng X, Yu K, Chen Z, Guo W. A prospective phase II single-arm study and predictive factor analysis of irinotecan as third-line treatment in patients with metastatic gastric cancer. Ther Adv Med Oncol. 2024 Feb 28;16:17588359241229433. doi: 10.1177/17588359241229433. eCollection 2024.

    PMID: 38425987DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Central Study Contacts

ZHIYU CHEN, M.D.

CONTACT

+862164175590zychan75@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2015

First Posted

January 26, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2018

Last Updated

January 26, 2016

Record last verified: 2015-11

Locations

CN(1)